Events

Upcoming Event

WEBINAR: What US Companies Need to Know about Selling Medical Devices into the EU: Key differences between the EU & US Regulatory & Legal Environment

Thu. December 14, 2017 12:00 pm - 1:30 pm

!Online.

Please join the European American Chamber of Commerce and the U.S. Commercial Service International Trade Administration, U.S. Department of Commerce for an expert presentation on the essentials for US companies to know about selling medical devices in the European Union.

Current Legal and Regulatory Framework and its evolution in the light of the new EU Regulations

• The current regulatory framework: Directives on Medical Devices 93/42/EEC; Active Implantable Medical Devices (90/385/EEC) and In Vitro Diagnostic Medical Devices (98/79/EC) and their implementation in EU Member States
• Changing regulatory framework: from EC Directives to the new Regulations: consequence of the replacement of “directives” with “regulations”
• The transition period after the entrance into force of the Regulations

Clinical evaluation of medical devices from the current regulatory framework to the new Regulations

• Conditions to perform clinical evaluations
• Application to the competent authorities for the performance of the clinical evaluations
• Substantial and non-substantial amendments
• Informed consent requirements
• The role of the Ethics Committees

Pre-market requirements from the current regulatory framework to the new Regulations

• Main requirements for the marketing of medical devices in EU: the CE marking;
• New pre-market scrutiny mechanism under the Regulations;
• Classification of medical devices and borderline cases (e.g., software stand-alone);
• Current and future role of the notified bodies
• How to get prepared to the entrance into force of the new Regulations

Post-market requirements from the current regulatory framework to the new Regulations

• The strengthening of post-market surveillance requirements
• The surveillance by the competent authorities
• The vigilance on medical devices by the operators
• The future EU database on medical devices and device tracability system